tbuckley/cabot-search huggingface dataset:
Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements
Authors: Jonathan R. Dubin, Jonathan R. Enriquez, An-Lin Cheng, Hunter Campbell, Akin Cil
Journal: JAMA Network Open (2023)

High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed.To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall.In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through December 31, 2021, giving a minimum 2-year follow-up after initial approval. Data were analyzed from July 6 to August 6, 2022. Retrospective, time-to-event analysis investigated the association between the number and type of supplements and risk of recall.Supplements submitted by manufacturers for FDA approval to modify devices.A mixed-effects Cox proportional hazards regression model with frailty terms was used, modeling device recall as an outcome variable during the observation period. A second model was performed for class 1 (high-risk) recall. Explanatory variables are the number of supplements, number of panel track supplements, and cardiovascular devices. Multivariable analysis was performed to identify independent risk factors for recall with hazard ratios (HRs) as the main end point.A total of 373 original PMA devices with 10 776 associated supplements were included in the analysis. A median 2.5 (IQR, 1.2-5.0) supplements per device were approved annually. Cardiovascular devices contributed 138 supplements (37.0%), followed by microbiology with 45 (12.1%). No other specialty contributed more than 10%. Multivariable analysis demonstrated that each increase of 1 supplement per year was associated with increased risk of recall (HR, 1.28 [95% CI, 1.15-1.44]; P < .001). For class 1 recall, increased number of supplements (HR, 1.32 [95% CI, 1.06-1.64]; P = .01) and cardiovascular vsnoncardiovascular classification of devices (HR, 3.51 [95% CI, 1.15-10.72]; P = .03) were significantly associated with an increased risk of recall.The findings of this cohort study suggest that PMA supplements are associated with an approximately 30% increased risk of any recall and class 1 recall. The FDA processes for approving modifications to high-risk medical devices should be reevaluated to optimize patient safety and public health.
Acute Respiratory Distress Following Percutaneous Coronary Intervention of Osteal Occlusion of Left Main Coronary Artery
Authors: Mochamad Yusuf Alsagaff, Makyhan Jibril Al Farabi, Arief Bakhtiar
Journal: JAMA Cardiology (2023)

A man in his late 50s had reduced left ventricle systolic function and hypokinesia of the anteroseptal, anterior, anterolateral, and septal walls. Lung ultrasound demonstrated multiple B-lines in both lung fields. What would you do next?
Interventions for sustainable surgery: a systematic review
Authors: Kyle Lam, Nishita Gadi, Amish Acharya, Jasmine Winter Beatty, Ara Darzi, Sanjay Purkayastha
Journal: International Journal of Surgery (2023)

Objective: To systematically evaluate interventions designed to improve the sustainability of surgical practice with respect to their environmental and financial impact. Background: Surgery contributes significantly to emissions attributed to healthcare due to its high resource and energy use. Several interventions across the operative pathway have, therefore, been trialed to minimize this impact. Few comparisons of the environmental and financial effects of these interventions exist. Materials and methods: A search of studies published up to 2nd February 2022 describing interventions to increase surgical sustainability was undertaken. Articles regarding the environmental impact of only anesthetic agents were excluded. Data regarding environmental and financial outcomes were extracted with a quality assessment completed dependent upon the study design. Results: In all, 1162 articles were retrieved, of which 21 studies met inclusion criteria. Twenty-five interventions were described, which were categorized into five domains: ‘reduce and rationalize’, ‘reusable equipment and textiles’, ‘recycling and waste segregation’, ‘anesthetic alternatives’, and ‘other’. Eleven of the 21 studies examined reusable devices; those demonstrating a benefit reported 40–66% lower emissions than with single-use alternatives. In studies not showing a lower carbon footprint, the reduction in manufacturing emissions was offset by the high environmental impact of local fossil fuel-based energy required for sterilization. The per use monetary cost of reusable equipment was 47–83% of the single-use equivalent. Conclusions: A narrow repertoire of interventions to improve the environmental sustainability of surgery has been trialed. The majority focuses on reusable equipment. Emissions and cost data are limited, with longitudinal impacts rarely investigated. Real-world appraisals will facilitate implementation, as will an understanding of how sustainability impacts surgical decision-making.
Concerns Over Diagnostic Accuracy of Fine-Needle Biopsy in Thyroid Nodule Diagnosis
Authors: Shijie Yang, Meijuan Tan, Xiequn Xu
Journal: JAMA Surgery (2023)

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Evaluation of Preferred Language and Timing of COVID-19 Vaccine Uptake and Disease Outcomes
Authors: Nasreen S. Quadri, Greg Knowlton, Gabriela Vazquez Benitez, Kirsten R. Ehresmann, Amy B. LaFrance, Terese A. DeFor, M. Kumi Smith, Erin M. Mann, Jonathan D. Alpern, William M. Stauffer
Journal: JAMA Network Open (2023)

Importance Beyond traditional race and ethnicity demographic characteristics, additional discrete data variables are needed for informed health interventions in the US. Objective To examine whether COVID-19 vaccine uptake patterns and associated disease outcomes differ among language preference groups. Design, Setting, and Participants A cohort study of 851 410 individuals aged 18 years or older in a large multispecialty health system in Minnesota and western Wisconsin was conducted between December 15, 2020, and March 31, 2022. Exposure Self-identified language preference and limited English proficiency (LEP) as measured by interpreter need were used to create subgroups using US census categories and attention to capture languages known to represent refugee groups. Main Outcomes and Measures The primary outcome was COVID-19 vaccination uptake rates and time to first vaccine. Secondary outcomes were rates of COVID-19–associated hospitalization and death. Results Most of the 851 410 participants (women, 493 910 [58.0%]; median age, 29 [IQR, 35-64] years) were US-born English speakers; 7.5% were born in other countries, 4.0% had a language preference other than English (LPOE), and 3.0% indicated LEP as measured by interpreter need. Marked temporal clusters were observed for COVID-19 vaccination uptake, hospitalizations, and deaths associated with primary series vaccine eligibility, booster availability, and COVID-19 variants. Delayed first-dose vaccine was observed with LPOE (hazard ratio [HR], 0.83; 95% CI, 0.82-0.84) and interpreter need (HR, 0.81; 95% CI, 0.80-0.82) compared with those with English language preference and proficiency. Patients with LPOE were approximately twice as likely to be hospitalized (rate ratio [RR], 1.85; 95% CI, 1.63-2.08) or die (RR, 2.13; 95% CI, 1.65-2.69). Patients with LEP experienced even higher rates of hospitalization (RR, 1.98; 95% CI, 1.73-2.25) and COVID-19–associated death (RR, 2.32; 95% CI, 1.79-2.95). Outcomes varied for individual language preference groups. Conclusions and Relevance In this study, delayed time to first-dose vaccine was associated with increased COVID-19 hospitalization and death rates for specific LPOE and LEP groups. The findings suggest that data collection of language preference and interpreter need provides actionable health intervention information. Standardized system-level data collection, including at a national level, may improve efficient identification of social groups with disproportionate health disparities and provide key information on improving health equity in the US.
Fatty acid desaturation by stearoyl-CoA desaturase-1 controls regulatory T cell differentiation and autoimmunity
Authors: Elien Grajchen, Melanie Loix, Paulien Baeten, Beatriz F. Côrte-Real, Ibrahim Hamad, Sam Vanherle, Mansour Haidar, Jonas Dehairs, Jelle Y. Broos, James M. Ntambi, Robert Zimmermann, Rolf Breinbauer, Piet Stinissen, Niels Hellings, Sanne G. S. Verberk, Gijs Kooij, Martin Giera, Johannes V. Swinnen, Bieke Broux, Markus Kleinewietfeld, Jerome J. A. Hendriks, Jeroen F. J. Bogie
Journal: Cellular and Molecular Immunology (2023)

The imbalance between pathogenic and protective T cell subsets is a cardinal feature of autoimmune disorders such as multiple sclerosis (MS). Emerging evidence indicates that endogenous and dietary-induced changes in fatty acid metabolism have a major impact on both T cell fate and autoimmunity. To date, however, the molecular mechanisms that underlie the impact of fatty acid metabolism on T cell physiology and autoimmunity remain poorly understood. Here, we report that stearoyl-CoA desaturase-1 (SCD1), an enzyme essential for the desaturation of fatty acids and highly regulated by dietary factors, acts as an endogenous brake on regulatory T-cell (Treg) differentiation and augments autoimmunity in an animal model of MS in a T cell-dependent manner. Guided by RNA sequencing and lipidomics analysis, we found that the absence of Scd1 in T cells promotes the hydrolysis of triglycerides and phosphatidylcholine through adipose triglyceride lipase (ATGL). ATGL-dependent release of docosahexaenoic acid enhanced Treg differentiation by activating the nuclear receptor peroxisome proliferator-activated receptor gamma. Our findings identify fatty acid desaturation by SCD1 as an essential determinant of Treg differentiation and autoimmunity, with potentially broad implications for the development of novel therapeutic strategies and dietary interventions for autoimmune disorders such as MS.
Effort-Cost Decision-making Among Individuals With Schizophrenia
Authors: Elodie Blouzard, Arnaud Pouchon, Mircea Polosan, Julien Bastin, Clément Dondé
Journal: JAMA Psychiatry (2023)

Importance Motivational impairments in schizophrenia are by definition associated with poor outcome. It is postulated that the reduction of goal-directed behavior arises from abnormal trade-offs between rewards and efforts. Objective To examine whether schizophrenia is associated with impairments in effort-cost decision-making. Data Sources For this systematic review and meta-analysis, the PubMed, ScienceDirect, PsycINFO, Embase, and ClinicalTrials.gov databases were searched from inception to July 2022 for studies that investigated effort-cost decision-making in schizophrenia. Search terms included effort , cost , and schizophrenia . Study Selection Consensual criteria for inclusion were peer-reviewed studies published in English that used a computerized effort-cost decision-making behavioral paradigm and compared individuals with schizophrenia with control individuals. Data Extraction and Synthesis The Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline was used for abstracting data. Data were extracted independently by 2 authors and then pooled using random-effects sizes and bayesian approaches. Main Outcomes and Measures The main outcomes were performance on effort-cost decision-making tasks requiring an effort-reward trade-off, measured by Hedges g effect size. Effects of moderators were tested with meta-regressions and subgroup analyses. Results Twenty studies involving 1503 participants were included: 837 individuals with schizophrenia (541 [64.6%] male; mean [SD] age, 35.89 [6.70] years) and 666 control individuals without schizophrenia (360 [54.1%] male; mean [SD] age, 34.16 [5.92] years). Participants with schizophrenia had significantly reduced willingness to expend effort for rewards compared with controls (k = 20; effect size, 0.43; 95% CI, 0.30-0.56; P &amp;amp;lt; .001; I 2 = 33.1%; Q test P = .08). The magnitude of the deficit was significantly greater for high-reward trials. The severity of negative symptoms was negatively associated with effort-cost decision-making (k = 8; effect size, −0.33; 95% CI, −0.50 to −0.15; P &amp;amp;lt; .001), while participants with a high number of negative symptoms had a significantly larger impairment in effort-cost decision-making (k = 5; effect size, 0.47; 95% CI, 0.10-0.84; P = .01). Conclusions and Relevance In this systematic review and meta-analysis, schizophrenia was associated with deficits in effort allocation as indexed by effort-cost decision-making tasks. Understanding the cognitive and neurobiological mechanisms driving effort allocation impairments may assist in developing novel interventions.
Racial and Ethnic Disparities in Locoregional Recurrence Among Patients With Hormone Receptor–Positive, Node-Negative Breast Cancer
Authors: Olga Kantor, Tari A. King, Rachel A. Freedman, Erica L. Mayer, Mariana Chavez-MacGregor, Larissa A. Korde, Joseph A. Sparano, Elizabeth A. Mittendorf
Journal: JAMA Surgery (2023)

Whether racial and ethnic disparities in locoregional recurrence (LRR) exist among patients with similar access to care treated in randomized clinical trials is unknown.
Targeting Wnt-ß-Catenin-FOSL Signaling Ameliorates Right Ventricular Remodeling
Authors: Sreenath Reddy Nayakanti, Aleksandra Friedrich, Poonam Sarode, Leili Jafari, Giovanni Maroli, Mario Boehm, Alice Bourgeois, Yann Grobs, Fatemeh Khassafi, Carsten Kuenne, Stefan Guenther, Swati Dabral, Jochen Wilhelm, Astrid Weiss, Astrid Wietelmann, Baktybek Kojonazarov, Wiebke Janssen, Mario Looso, Frances de Man, Steeve Provencher, Khodr Tello, Werner Seeger, Sebastien Bonnet, Rajkumar Savai, Ralph T. Schermuly, Soni Savai Pullamsetti
Journal: Circulation Research (2023)

Background: The ability of the right ventricle (RV) to adapt to an increased pressure afterload determines survival in patients with pulmonary arterial hypertension. At present, there are no specific treatments available to prevent RV failure, except for heart/lung transplantation. The wingless/int-1 (Wnt) signaling pathway plays an important role in the development of the RV and may also be implicated in adult cardiac remodeling. Methods: Molecular, biochemical, and pharmacological approaches were used both in vitro and in vivo to investigate the role of Wnt signaling in RV remodeling. Results: Wnt/β-catenin signaling molecules are upregulated in RV of patients with pulmonary arterial hypertension and animal models of RV overload (pulmonary artery banding-induced and monocrotaline rat models). Activation of Wnt/β-catenin signaling leads to RV remodeling via transcriptional activation of FOSL1 and FOSL2 (FOS proto-oncogene [FOS] like 1/2, AP-1 [activator protein 1] transcription factor subunit). Immunohistochemical analysis of pulmonary artery banding -exposed BAT-Gal (β-catenin-activated transgene driving expression of nuclear β-galactosidase) reporter mice RVs exhibited an increase in β-catenin expression compared with their respective controls. Genetic inhibition of β-catenin, FOSL1/2, or WNT3A stimulation of RV fibroblasts significantly reduced collagen synthesis and other remodeling genes. Importantly, pharmacological inhibition of Wnt signaling using inhibitor of PORCN (porcupine O-acyltransferase), LGKK-974 attenuated fibrosis and cardiac hypertrophy leading to improvement in RV function in both, pulmonary artery banding - and monocrotaline-induced RV overload. Conclusions: Wnt- β-Catenin-FOSL signaling is centrally involved in the hypertrophic RV response to increased afterload, offering novel targets for therapeutic interference with RV failure in pulmonary hypertension.
Cancer Moonshot Plan Announced
Authors: Emily Harris
Journal: JAMA (2023)

Urine Tests May Miss More Than 400 000 STIs in the US Every Year Using vaginal swabs to test for sexually transmitted infections (STIs) picked up significantly more cases of Chlamydia trachomatis and Neisseria gonorrhoeae than using urine tests, according to a metaanalysis of 28 studies conducted from 1995 through 2021.Vaginal swabs were also more sensitive for Trichomonas vaginalis, although the difference between test types was not significant.Despite guidelines released in 2014 by the US Centers for Disease Control and Prevention in favor of vaginal swabs, most samples analyzed by public health laboratories continue to be urine.The researchers estimated that depending on urine rather than vaginal swab testing could result in more than 400 000 missed STI cases each year."[V]aginal sampling should be the initial choice offered to patients," the researchers wrote in the Annals of Family Medicine, with urine samples only collected from those for whom a vaginal sample is unacceptable.Implementation research is needed to change physicians' go-to tests, they noted.
The blunted loop diuretic response in acute heart failure is driven by reduced tubular responsiveness rather than insufficient tubular delivery. The role of furosemide urine excretion on diuretic and natriuretic response in acute heart failure
Authors: Jan Biegus, Robert Zymliński, Jeffrey Testani, Marat Fudim, Zachary L. Cox, Mateusz Guzik, Gracjan Iwanek, Magdalena Hurkacz, Danuta Raj, Dominik Marciniak, Barbara Ponikowska, Piotr Ponikowski
Journal: European Journal of Heart Failure (2023)

Diuretic response in heart failure is blunted when compared to healthy individuals, but the pathophysiology underlying this phenomenon is unclear. We aimed to investigate whether the diuretic resistance mechanism is related to insufficient furosemide tubular delivery or low tubular responsiveness.We conducted a prospective, observational study of 50 patients with acute heart failure patients divided into two groups based on previous furosemide use (furosemide naïve: n = 28 [56%] and chronic furosemide users: n = 22 [44%]). Each patient received a protocol-derived, standardized furosemide dose based on body weight. We measured diuretic response and urine furosemide concentrations. The furosemide naïve group had significantly higher urine volumes and natriuresis when compared to chronic users at all timepoints (all p < 0.05). Urine furosemide delivery was similar in furosemide naïve versus chronic users after accounting for differences in estimated glomerular filtration rate (28.02 [21.03-35.89] vs. 29.70 [18.19-34.71] mg, p = 0.87). However, the tubular response to delivered diuretic was dramatically higher in naïve versus chronic users, that is the urine volume per 1 μg/ml of urine furosemide at 2 h was 148.6 ± 136.1 versus 50.6 ± 56.1 ml (p = 0.005).Patients naïve to furosemide have significantly better diuresis and natriuresis when compared to chronic furosemide users. The blunted diuretic response in patients with chronic loop diuretic exposure is driven by decreased tubular responsiveness rather than insufficient furosemide tubular delivery.
Direct Oral Anticoagulants Versus Warfarin Across the Spectrum of Kidney Function: Patient-Level Network Meta-Analyses From COMBINE AF
Authors: Josephine Harrington, Anthony P. Carnicelli, Kaiyuan Hua, Lars Wallentin, Manesh R. Patel, Stefan H. Hohnloser, Robert P. Giugliano, Keith A.A. Fox, Ziad Hijazi, Renato D. Lopes, Sean D. Pokorney, Hwanhee Hong, Christopher B. Granger
Journal: Circulation (2023)

There is uncertainty surrounding the use of direct oral anticoagulants (DOACs) in patients with kidney dysfunction.
Effect of Smartphone App Postoperative Home Monitoring After Oncologic Surgery on Quality of Recovery
Authors: Claire Temple-Oberle, Spencer Yakaback, Carmen Webb, Golpira Elmi Assadzadeh, Gregg Nelson
Journal: JAMA Surgery (2023)

There has been an increase in health care-focused smartphone apps, including those for encouraging healthy behaviors and managing chronic conditions, but app-assisted postsurgical care has yet to be fully explored.
Improvement of Hailey-Hailey Disease With Topical Cinacalcet, 3%, Ointment
Authors: John R. Edminister, Heli A. Patel, Jessica N. Pixley, William W. Huang, Joseph L. Jorizzo
Journal: JAMA Dermatology (2023)

This case report describes a woman in her 50s with a large, crusted, erythematous plaque on the right chest that was consistent with a Hailey-Hailey disease flare.
CTLA4 depletes T cell endogenous and trogocytosed B7 ligands via cis-endocytosis
Authors: Xiaozheng Xu, Preston Dennett, Jibin Zhang, Alice Sherrard, Yunlong Zhao, Takeya Masubuchi, Jack D. Bui, Xu Chen, Enfu Hui
Journal: The Journal of Experimental Medicine (2023)

CD28 and CTLA4 are T cell coreceptors that competitively engage B7 ligands CD80 and CD86 to control adaptive immune responses. While the role of CTLA4 in restraining CD28 costimulatory signaling is well-established, the mechanism has remained unclear. Here, we report that human T cells acquire antigen-presenting-cell (APC)–derived B7 ligands and major histocompatibility complex (MHC) via trogocytosis through CD28:B7 binding. Acquired MHC and B7 enabled T cells to autostimulate, and this process was limited cell-intrinsically by CTLA4, which depletes B7 ligands trogocytosed or endogenously expressed by T cells through cis-endocytosis. Extending this model to the previously proposed extrinsic function of CTLA4 in human regulatory T cells (Treg), we show that blockade of either CD28 or CTLA4 attenuates Treg-mediated depletion of APC B7, indicating that trogocytosis and CTLA4-mediated cis-endocytosis work together to deplete B7 from APCs. Our study establishes CTLA4 as a cell-intrinsic molecular sink that limits B7 availability on the surface of T cells, with implications for CTLA4-targeted therapy.